MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD MICRO-FINE ULTRA¿ PEN NEEDLE

Catalog Number	320141
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that a bd micro-fine ultra¿ pen needle had leakage between the needle and the plastic hub.There was no report of exposure, serious injury, or medical intervention.
Event or Problem Description
It was reported that a bd micro-fine ultra pen needle had leakage between the needle and the plastic hub.There was no report of exposure, serious injury, or medical intervention.
Additional Manufacturer Narrative
Forty four sealed and intact 32g x 4mm pen needle samples were returned from lot.No.8010972, cat.320141.Clog testing was carried out on 30 of the returned samples and no issues were observed.A lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed per the applicable operations and met qc specifications.No issues were observed with the returned samples therefore no root cause can be identified.Based on an evaluation of severity and occurrence it was determined that no corrective action is required at this time.

• Brand Name: BD MICRO-FINE ULTRA¿ PEN NEEDLE
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• MDR Report Key: 7918996
• Report Number: 9616656-2018-00212
• Device Sequence Number: 11275810
• Product Code: FMI
• UDI-Device Identifier: 30382903814672
• UDI-Public: 30382903814672
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K131358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 320141
• Device Lot Number: 8010972
• Initial Date Received by Manufacturer: 09/06/2018
• Supplement Date Received by Manufacturer: 09/06/2018
• Initial Report FDA Received Date: 09/28/2018
• Supplement Report FDA Received Date: 10/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other